CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)
FDA 510(k) K162281 · Sebia
510(k) numberK162281
Submission
- Device name
- CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)
- Applicant
- Sebia
Norcross, GA, US - Received
- August 15, 2016
- Decision date
- February 17, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LCP – Assay, Glycosylated Hemoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7470
- Specialty
- Hematology
Other 510(k)s with product code LCP
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|---|---|---|---|
| K221326 | Nova Allegro HbA1c Assay, Nova Allegro AnalyzerLCP · Dual Track | Nova Biomedical Corporation | 11/22/2024SE |
| K231465 | Q-Pad Test SystemLCP · Traditional | Qurasense | 12/06/2023SE |
| K214117 | Afinion HbA1c, Afinion 2 and Alere Afinion AS100 AnalyzerLCP · Dual Track | Abbott Diagnostics Technologies AS | 09/27/2023SE |
| K192987 | Aina HbA1c Monitoring System 2LCP · Traditional | Jana Care, Inc. | 03/26/2020SE |
| K192369 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitLCP · Traditional | Ixensor Co, Ltd. | 10/29/2019SE |
| K183230 | OneDraw A1C Test SystemLCP · Traditional | Drawbridge Health, Inc. | 08/15/2019SE |
| K181915 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitLCP · Traditional | Ixensor Co, Ltd. | 04/12/2019SE |
| K180509 | Quo-Test A1c SystemLCP · Dual Track | Ekf-Diagnostic GmbH | 02/16/2019SE |
| K173127 | skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent…LCP · Traditional | Skyla Corporation H.S.P.B | 09/25/2018SE |
| K170623 | ACE Hemoglobin A1c (HbA1c) ReagentLCP · Traditional | Alfa Wassermann Diagnostic Technologies, LLC | 02/27/2018SE |
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| 510(k) | Device | Decision |
|---|---|---|
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| K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2DFH · Traditional | 02/23/2024SE |
| K210623 | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2DFH · Traditional | 11/18/2022SE |
| K203184 | HYDRASHIFT 2/4 isatuximabCFF · Traditional | 11/12/2021SE |
| K192095 | CAPI 3 Immunotyping, Capillarys 3 TeraCFF · Traditional | 11/01/2019SE |
| K190851 | HYDRASHIFT 2/4 daratumumabCFF · Special | 05/02/2019SE |
| K180762 | Capi 3 Hemoglobin(E)GKA · Traditional | 12/14/2018SE |
| K171861 | CAPILLARYS Hb A1cPDJ · Traditional | 02/07/2018SE |
| K172195 | HYDRASHIFT 2/4 daratumumab, daratumumab ControlCFF · Traditional | 01/11/2018SE |
| K171537 | CAPI 3 Hb A1cPDJ · Traditional | 09/12/2017SE |
Questions and answers
When was CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) cleared by the FDA?
CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) (K162281) received a 510(k) decision of Substantially Equivalent on February 17, 2017, 186 days after the submission was received.
What is the product code of K162281?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.